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Can a single dose of radiation during surgery improve pancreatic cancer outcomes?

NCT ID NCT05141513

Disease control Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This trial is testing whether giving a single dose of radiation directly to the tumor area during surgery is safe for people with localized pancreatic cancer. Participants first receive standard chemotherapy and stereotactic body radiation therapy (SBRT), then at the time of surgical removal, they receive intraoperative radiation therapy (IORT). The study aims to evaluate the short-term and long-term side effects of this additional radiation, with the hope of improving local control of the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intraoperative radiation therapy (IORT) using high-dose-rate brachytherapy
What this could lead to
If safe and effective, this approach could improve local control of pancreatic cancer after surgery, potentially extending survival or delaying recurrence.
What could go wrong
This is an early-phase safety study with a small number of participants. The added radiation may increase post-operative complications, and the benefit over standard care is not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

May 2022

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age \> 18 years old 2. Resectable/BRPC/LAPC as defined by NCCN guidelines (Figure 1) as follows confirmed via CT, EUS, or other imaging modalities. 3. ECOG performance status 0-2 4. Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site. 5. Candidate for SBRT at JHU 6. Upfront treatment with multi-agent chemotherapy 7. Candidate for surgical exploration at JHU Exclusion Criteria: 1. Previous thoracic/abdominal radiation therapy 2. Unable to receive SBRT at JHU 3. Duodenal invasion detected on imaging which would exclude candidacy for SBRT 4. Tumor located in pancreatic body or tail 5. Unable to undergo Whipple procedure 6. Evidence of disease not localized to the pancreas 7. Any arterial reconstruction during surgery 8. Currently enrolled in another investigational drug or device trial that clinically interferes with this study 9. Unable to comply with study requirements or follow-up schedule 10. Women of child bearing potential or sexually active fertile men with partners who are women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic cancer

Contacts and locations

Locations

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21205, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.